Company Announcement

On January 6, 2016, Cook Medical initiated a voluntary recall of 360 specific lots of Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to catheter tip fracture and/or separation. Globally, 17,827 devices are subject to this recall. The recalled products are specific versions and lot numbers of the Single Lumen Central Venous Catheter Sets and Trays, Single Lumen Pressure Monitoring Sets, Femoral Artery Pressure Monitoring Catheter Sets and Trays, and Radial Artery Pressure Monitoring Catheter Sets and Trays. These products are intended for use in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.

During an internal inspection, a catheter exhibited the potential for catheter tip fracture and/or separation. Further investigation revealed that the technique used by the product assembler while tipping the catheter likely contributed to this nonconformance. No reports of illness or injury have been associated with this issue to date. Potential adverse events that may occur as a result of catheter tip fracture and/or separation include loss of device function, the need for medical intervention to retrieve a separated segment, and complications resulting from a separated tip occluding blood flow to end organs. Examples of such complications include stroke, kidney injury, or damage to the intestines or limbs.

The Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays in this recall were distributed globally between April 24, 2015, and October 23, 2015. Product can be identified by the part number and lot number that are provided on the outer package product label. The lot numbers for products that are subject to this recall can be found below:

Cook Medical notified its customers and distributors by recall notification letters in January. All customers and distributors should quarantine and discontinue use of all affected units and return the affected product to the company as soon as possible for credit.

Cook Medical notified the FDA and other global regulatory agencies of this action.

Consumers with questions may contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812­339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or via email at FieldActionsNA@cookmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, via regular mail or via fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the preaddressed form, or submit via fax to 1-800­FDA-0178.

Adverse events may also be reported to Cook Medical Customer Relations at 1-800-457-4500 or 1­812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or via email at CustomerRelationsNA@cookmedical.com.